Minutes matter when it comes to treating sepsis, according to a new analysis of nearly 50,000 patients at 149 hospitals.
Following the death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition.
The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life.
Now, five years after the boy’s death, a new study is the first to offer scientific evidence that “Rory’s Regulations” work. The findings give fuel to other states pursuing rapid sepsis care initiatives.
Sepsis occurs when the body’s response to an infection injures its own tissues and organs. It is the number one killer of hospital patients—more than 1 in 5 don’t survive. At least 1.5 million sepsis cases occur in the US each year.
“There is considerable controversy about how rapidly sepsis must be treated,” says lead author Christopher W. Seymour, assistant professor of critical care medicine and emergency medicine at the University of Pittsburgh. “Some question the benefit of rapid treatment with protocols, saying they can have unintended side effects and be a distraction in busy emergency departments. After reviewing the data, we can finally say that faster is better when it comes to sepsis care.”
Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress), and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.”
Published in the New England Journal of Medicine, the study found that 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent.
The results come on the heels of an international analysis of several clinical trials, none of which found a benefit from a standardized approach to treating sepsis when compared to good physician judgment.
But, those clinical trials picked up after the initial urgent resuscitation period was over, and that more than 3 out of 4 sepsis patients in those trials had received elements of the three-hour bundle before they went on to the intensive care unit for further evaluation, says senior author Mitchell Levy, professor of medicine at the Warren Alpert Medical School of Brown University.
“When the patient is newly diagnosed and possibly still in the emergency department is when it is most important to check the boxes of the three-hour bundle,” Levy says. “Minutes matter, and it is critical to perform the correct tests and get the patient antibiotics as fast as possible.”
In an editorial in the same issue of the journal, Tina Batra Hershey of the University of Pittsburgh’s Graduate School of Public Health and Jeremy M. Kahn of Pitt Public Health and the department of critical care medicine examine the potential of additional state sepsis mandates in light of the new study and the regulations—that they say represent a major shift in the use of health policy to improve the quality of health care, rather than using market-based incentives and reimbursement penalties.
“Sepsis is a public health crisis worthy of a policy response,” they write, adding that such policies should give hospitals the flexibility to ensure they can evolve as the science of sepsis care advances. “More direct efforts are needed to ensure that the government response to sepsis maximizes benefits, minimizes harms, and remains responsive to a complex and evolving evidence base.”
Other researchers from the University of Pittsburgh, the University of Michigan, the New York State Department of Health; Ohio State University; and Washington University are coauthors of the study. The National Institutes of Health and a VA Health Services Research & Development supported the work.
Source: University of Pittsburgh